Uncategorized
Medical device compliance is an important aspect of the medical industry that ensures the safety and effectiveness of medical devices. Medical devices range from simple instruments, such as tongue depressors, to complex devices, such as implantable defibrillators. ...
Uncategorized
Medical devices play a critical role in healthcare by improving the diagnosis, treatment, and prevention of various diseases. As a result, they are subject to strict regulatory requirements aimed at ensuring their safety and effectiveness. However, even with these...
FDA
Medical devices are an essential component of modern healthcare, and their safety and efficacy are crucial for the well-being of patients. To ensure that medical devices are safe for use and meet certain quality standards, the Food and Drug Administration (FDA) in the...
RegDesk News/Info
RIMS is a growing category of regulatory software solutions designed to help RA teams achieve faster submissions with fewer rejections. However, despite their novel nature, most platforms are already behind the times, technologically speaking. This article discusses...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document that addresses the information accompanying (active) implantable medical devices, including patient information...
